A RANDOMIZED, PROSPECTIVE, DOUBLE-BLINDED, PLACEBO-CONTROLLED ( SHAM-CONTROLLED

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究旨在评估adacollapheresis系统重复治疗的潜在益处和安全性。一旦研究医生确定受试者符合参与条件，他们将被要求审查并签署同意书。然后，研究医生将通过获取完整的病史、目前的药物使用情况、收集血液、尿液和粪便样本、进行完整的身体检查和柔性乙状结肠镜检查来确认患者的资格。患者将接受5-15分钟的分离试验，以确定有良好的静脉通路。然后，受试者将随机接受阿达科列或安慰剂治疗。在阿达科柱臂中，血液将通过阿达科柱。在安慰剂治疗中，血液会通过一根塑料线流过阿达科柱。受试者共接受10次单采治疗：前2周每周2次，之后6周每周1次。将在第12周评估受试者的反应，之后他们将进入一个随访计划，在该计划中，受试者将每4周随访一次，以评估疾病活动，直到第24周。在整个研究过程中，受试者将填写问卷来评估生活质量，并进行身体和实验室评估（血液和尿液），以监测治疗的有效性和安全性。研究期间将进行两次乙状结肠镜检查。入学没有种族或民族限制。然而，以下个人将被排除在外，因为他们是弱势群体：18岁以下的患者、孕妇、有生育潜力的女性，她们不同意在整个研究过程中使用节育措施。参加研究的受试者将通过首字母缩写和5位受试者ID号码进行识别，该号码将与密码保护的计算机文件中的患者姓名相关联。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study involves research to evaluate the potential benefits and safety of repeated treatment with the Adacolumn Apheresis System. Once the study doctor has determined that a subject is eligible for participation, they will be asked to review and sign a consent form. The study doctor will then confirm eligibility by obtaining a complete medical history, current medication use, collecting blood, urine, and stool samples, conducting complete physical exam and flexible proctosigmoidoscopy. Patients will receive a 5-15 minute trial of the apheresis to establish that there is good venous access. Subjects will then be randomized to receive either Adacolumn or placebo treatment. In the Adacolumn arm the blood will pass through the Adacolumn. In the placebo treatment, blood will go around the Adacolumn through a plastic line. Subjects receive a total of 10 apheresis treatments: 2 times a week for the first 2 weeks and then once a week for 6 more weeks. Subjects will be evaluated for response at week 12 after which they will enter into a follow-up program in which subjects will be followed every 4 weeks to assess disease activity until week 24. Throughout the study subjects will fill out questionnaires to assess quality of life and physical and lab evaluations (blood and urine ) will be done to monitor effectiveness and safety of treatment. A sigmoidoscopy will be performed twice during the study. There will be no racial or ethnic limitations for enrollment. The following individuals will, however, be excluded as they represent vulnerable populations: patients under 18 years, pregnant women, and women of reproductive potential who don t agree to use birth control throughout the study. Subjects enrolled in the study will be identified by initials and 5 digit subject ID numbers which will be linked to the patient s names in a password protected computer file.